CLINICAL TRIAL UPDATE

DRY AMD

► Study: Age-Related Eye Disease Study II (AREDS II)

Sponsor: National Eye InstituteStatus: Enrolling patientsPurpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing a lower dose of zinc and eliminating beta-caroteneDesign: Phase 3, randomized, prospective, multicenter trialNumber of Patients: 4000Number of Clinical Centers: 80 plusInclusion Criteria: Age 55 years to 80 years; bilateral large drusen (>125 μm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eyeExclusion Criteria: Choroidal neovascularization (CNV) associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser)Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

► Study: Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry AMDSponsor: SirionStatus: Currently enrollingPurpose: To determine the efficacy of fenretinide in the treatment of geographic atrophy in subjects with the dry form of AMDDesign: Multicenter, randomized, double-masked, placebo-controlled, dose comparisonNumber of Patients: 225Inclusion Criteria: Age from 50-89 years old; must have geographic atrophy from AMD in 1 or both eyesExclusion Criteria: Geographic atrophy due to any disease other than AMDContact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

► Study: OMEGA: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular DegenerationSponsor: Othera PharmaceuticalsStatus: Enrolling patientsPurpose: To compare the ability of 2 doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with AMDStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 200Inclusion Criteria: Must have a clinical diagnosis of GA in 1 or both eyes; must be of nonchildbearing potentialExclusion Criteria: GA secondary to any condition other than AMD in the study eye; BCVA of 20/200 or worse in nonstudy eye; history of CNV in either eye; need for contact lenses in study eyeInformation: clinicaltrials@othera.com

► Study: Effects of Sun Filters on Age-Related Macular Degeneration in People With Lens ImplantsSponsor: National Institute of Child Health and Human Development (NICHD)Status: Currently enrollingPurpose: To test a new method for preventing worsening of AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease.Study Design: Natural History, Longitudinal, Defined Population, Prospective StudyNumber of Patients: 40Inclusion Criteria: Patients will be local area residents who average greater than or equal to 2 hours outdoors daily, who are willing to follow the protocol of wearing our bicolor sunglasses whenever outdoors in daylight, to keep a log book of use, and to return periodically to NIH for our noninvasive imaging studies.Exclusion Criteria: Wet AMD; prior eye disorders; diabetes or current chemotherapyInformation: (800) 411-1222

WET AMD

► Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMDSponsor: OSI/PfizerStatus: Enrolling patientsPurpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatmentDesign: Treatment, non-randomized, open-label, uncontrolled, single group assignmentNumber of Patients: 1000Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMDInformation: (866) 622-8436

► Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMDSponsor: Vitreous Retinal Macula Consultants of New York; GenentechStatus: Enrolling patientsPurpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularizationDesign: Treatment, nonrandomized, open-label, active control, parallel assignment, safety/efficacy studyNumber of Patients: 15Inclusion Criteria: BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone area of the CNV must occupy at least 50% of the total lesion; lesion must be ≤4000 μm in greatest linear dimension (GLD)Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to other causes than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroidsContact: (212) 452-6902

► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular DegenerationSponsor: Novartis/Greater Houston Retinal ResearchStatus: Currently enrollingPurpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMDDesign: Treatment, Randomized, Open Label, Dose-Comparison, Parallel Assignment, Efficacy StudyNumber of Patients: 30Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and or ICG; visual acuity not better than 20/32 and not worse than 20/320 by ETDRS refractionExclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study; prior enrollment in any study for AMDInformation: http://www.houstonretina.com/

► Study: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular DegenerationSponsor: AllerganStatus: Currently enrollingPurpose: To evaluate multiple doses of AGN211745 (previously known as Sirna- 027) in treatment of subfoveal CNV associated with AMDDesign: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 135Inclusion Criteria: ≥50 years with "wet" AMD as determined by an ophthalmologist; decrease in VA (20/40 to 20/400) in at least 1 eyeExclusion Criteria: Uncontrolled systemic disease; history of heart attack or stroke within 1 year of study entry; symptomatic coronary artery disease; cataracts that interfere with visionInformation: clinicaltrials@allergan.com

► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal NeovascularizationSponsor: NovartisStatus: Currently enrollingPurpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMDDesign: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 318Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to ANDExclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eyeInformation: Brandi Teske, bteske@westcoastretina.com

► Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMDSponsor: Quark Biotech, Inc.Status: Enrolling patientsPurpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injectionStudy Design: Treatment, Non-Randomized, Open-Label, Uncontrolled, Single Group Assignment, Safety StudyNumber of Patients: 42Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months; history of intraocular surgery other than cataract surgery or of retinal detachment in the study eyeInformation: (212) 452-6902

► Study Name: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMDSponsor: Barnes Retina InstituteStatus: Enrolling patientsPurpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with VisudyneStudy Design: Treatment, Randomized, Open-Label, Active Control, Single Group Assignment, Safety/Efficacy StudyInclusion Criteria: Treatment-naive patients with active, subfoveal, exudative AMD; visual acuity of 20/40-20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other that CNV must be less than 50% of the total lesion size; lesion must be <5400 μm in greatest linear dimension (GLD); lesion size <10 disc areas (DAs)Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment; subretinal hemorrhage >50% of the total lesion; intraocular pressure greater than 30 mm Hg on 2 pressure-lowering medications; severe disciform scarring; advanced glaucoma; allergies to porfins or a known hypersensitivity to any component of Visudyne; porphyria, pregnancy, or lactationInformation: bristudies@barnesretina institute.com

► Study: TAPER: Second-line Therapy to Treat AMD for Patients Not Responding Well to Lucentis Therapy by ItselfSponsor: Vitreous Retina Macula Consultants of New York/QLT Inc.Status: Enrolling patientsPurpose: To demonstrate that Visudyne-Lucentis-Dexamethasone triple therapy will give similar efficacy and safety results as Lucentis monotherapyStudy Design: Randomized, Masked, Efficacy StudyInclusion Criteria: Patients with subfoveal CNV due to AMD who, after 2 to 6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4 to 8 weeks after the last treatment; all lesion composition types with a lesion GLD ≥5400 μm (approximately ≥9 DA); BCVA score of 25 to 73 letters (approximate Snellen equivalent of 20/40 to 20/320)Exclusion Criteria: Subfoveal geographic atrophy or subfoveal fibrosis in the study eye; intraocular surgery within 3 months of enrollmentInformation: (604) 742-1025

► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular DegenerationSponsor: Potentia Pharmaceuticals, Inc.Status: Currently enrollingPurpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD.Study Design: Prospective, uncontrolled, non-randomized, single-masked, singledose escalation studyNumber of Patients: 18Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 mm and presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its FA features; lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/100 or worse in the study eye as measured on an ETDRS chartExclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema (DME), severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within 3 months of enrolment; presence of hemorrhage greater than 50% of the CNV lesion; history of treatment for CNV in the study eye, peribulbar corticosteroid injection within 6 months prior to the start of the trial, or oral steroid use at any time during the 30 days prior to randomization; intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization; medical problems that make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections; history of coronary artery disease or cerebral vascular disease; hypersensitivity to fluoresceinInformation: federico@potentia pharma.com

► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMDSponsor: Oregon Health and Science UniversityStatus: Currently enrollingPurpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatmentStudy Design: Treatment, Non-Randomized, Open-Label, Uncontrolled, Single Group Assignment, Efficacy StudyNumber of Patients: 300Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS)Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye; acuity loss or central field loss from non-AMD cause; pigment epithelial detachment without evidence of CNV; individuals in whom Lucentis is contraindicated; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraceptionInformation: (503) 494-3616

► Study: Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular DegenerationSponsor: University of California, Davis/GenentechStatus: Currently enrollingPurpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safeStudy Design: Natural History, Longitudinal, Defined Population, Prospective StudyInclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 Disc Area; submacular hemorrhage less than 75% of total lesion; submacular fibrosis less than 25% of total lesionExclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or subtenon's Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months; other concurrent retinopathy or optic neuropathyInformation: (916) 734-6303

► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)Sponsor: Regeneron/BayerStatus: Currently enrollingPurpose: To study the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration.Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel AssignmentNumber of Patients: 1200Inclusion Criteria: Men and women |≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; ETDRS BCVA of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye; subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270o by visible CNV); scar or fibrosis, making up >50% of total lesion in the study eye; scar, fibrosis, or atrophy involving the center of the foveaInformation: vegf.trap@regeneron.com

► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMDSponsor: Jerini OphthalmicStatus: Currently enrollingPurpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eyeStudy Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety StudyNumber of Patients: 36Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal choroidal neovascularization (CNV) due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≥12 DA, of which at least 50% must be active CNV; for patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks; clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening; intraocular pressure of 21 mm Hg or less; retinal thickness ≥250 μm by OCT.Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; presence of pigment epithelial tears or rips; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks.Information: (919) 226-1440 ×325

SCREENING

► Study: Evaluation and Treatment of Patients with Retinal DiseaseSponsor: National Eye InstituteStatus: Enrolling patientsPurpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this areaDesign: Natural historyNumber of Patients: 500Inclusion Criteria: Diagnosis of AMDExclusion Criteria: Inability to be followed for 3 yearsContact: (800) 411-1222

► Study: Screening for Studies on Retinovascular DiseasesSponsor: National Eye InstituteStatus: Enrolling patientsPurpose: To help recruit patients for National Eye Institute (NEI) studies of the retinaDesign: Natural historyNumber of Patients: 1500 Inclusion andExclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study; all studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and womenContact: (800) 411-1222

► Study: Genetic Factors in AMDSponsor: National Eye InstituteStatus: Enrolling patientsPurpose: To examine whether certain poly morphisms predispose people to develop AMDDesign: ScreeningNumber of Patients: 400Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 μm; absence of other diagnostic criteria for AMDExclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of papillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases)Information: (800) 411-1222

► Study: Screening for Studies on Inherited Eye DiseasesSponsor: National Eye InstituteStatus: Currently enrollingPurpose: To help recruit patients for National Eye Institute (NEI) studies on inherited eye diseasesDesign: Natural HistoryNumber of Patients: 800Inclusion/Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this studyInformation: (800) 411-1222

RETINAL IMAGING STUDIES

► Study: Retinal Imaging in Patients With Inherited Retinal DegenerationsSponsor: University of California-San Francisco/University of California-BerkeleyStatus: Enrolling patientsPurpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser OphthalmoscopeDesign: Natural History, Longitudinal, Defined Population, Prospective StudyNumber of Patients: 130Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC BerkeleyExclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgeryInformation: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu

► Study: Novel Diagnostics With Optical Coherence Tomography: Retinal ImagingSponsor: University of PittsburghStatus: Currently enrollingPurpose: To evaluate OCT and FDAapproved device used to image diseases of the eyeDesign: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective StudyNumber of Patients: 1500Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and various other eye diseases. Also must be able to fixate on target.Exclusion Criteria: Fundus not visible or opaque mediaInformation: (412) 647-2375

► Study: Safety and Tolerability of MS-R001 in Patients With DME Secondary to Diabetic RetinopathySponsor: MacuSightStatus: Currently enrollingPurpose: To determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathyStudy Design: Randomized, Open-Label, Dose-Comparison, Single Group Assignment, Safety StudyNumber of Patients: 30Inclusion Criteria: Diagnosis diabetes mellitus; VA of 20/40 to 20/200 in study eyeExclusion Criteria: Any other ocular disease that could compromise vision in the study eye; intraocular surgery of the study eye within 90 days prior to study start; capsulotomy of the study eye within 30 days prior to study startInformation: (602) 222-2221 or (817) 749-0180

► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular EdemaSponsor: AllerganStatus: Enrolling patientsPurpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edemaStudy Design: Treatment, Randomized, Double-Blind, Dose-Comparison, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 860Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse); visual acuity in other eye no worse than 20/200Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparinInformation: clinicaltrials@allergan.com

► Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME)Sponsor: NEI/Genentech/AllerganStatus: Currently enrollingPurpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab aloneStudy Design: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Efficacy StudyNumber of Patients: 701Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2)Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry; known allergy to any component of the study drug; blood pressure >180/110 (systolic above 180 OR diastolic above 110); myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; pregnancyInformation: (866) 372-7601 ×218

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular EdemaSponsor: Diabetic Retinopathy Clinical Research NetworkStatus: Currently enrollingPurpose: To determine if ranibizumab alone or ranibizumab added to laser photocoagulation is more efficacious than photocoagulation alone, and if so, to determine if combining ranibizumab with photocoagulation reduces the total number of injections needed to obtain these benefitsStudy Design: Randomized, Multicenter Clinical TrialNumber of Patients: 700Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; DME involving the center of the macula (OCT central subfield thickness >250 μm) responsible for VA of 20/32 or worseInformation: http://public.drcr.net/DRCRnetstudies/studies/ProtocolI_lrtdme/ProtIInfo.html

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic RetinopathySponsor: Diabetic Retinopathy Clinical Research NetworkStatus: Currently enrollingPurpose: To determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of VA impairment that can occur following PRP and increase the chances of at least short-term VA improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for PDRStudy Design: Prospective, Multicenter Randomized Clinical TrialNumber of Patients: 380Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; study eye with proliferative diabetic retinopathy for which the investigator intends to perform fullscatter photocoagulation; DME involving the center of the macula (OCT central subfield thickness >250 μm) and reducing VA to 20/32 or worseInformation: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpd r/ProtJInfo.html

► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic RetinopathySponsor: NEI/Genentech/AllerganStatus: Currently enrollingPurpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatmentStudy Design: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Efficacy StudyNumber of Patients: 380Inclusion Criteria: Type 1 or 2 diabetics age ≥18 yearsExclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization; macular edema is considered to be due to a cause other than DME; ocular condition is present such that, in the opinion of the investigator, preventing VA loss would not improve from resolution of macular edema; substantial cataract that, in the opinion of the investigator, is likely to be decreasing VA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal); history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment)Information: (866) 372-7601

► Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes MellitusSponsor: GenentechStatus: Currently enrollingPurpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2)Study Design: TreatmentNumber of Patients: 366Inclusion Criteria: Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea with central macular thickness >275 μm in the center subfield, as assessed on OCT and confirmed by the central reading center at screening and by the evaluating physician on Day 0; known duration of DME of ≥2 years; BCVA score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; decrease in vision determined to be to the result of DME and not to other causesExclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry; previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of study entry; PDR in the study eye, with the exception of inactive, fibrotic PDR that has regressed following panretinal laser photocoagulation; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eyeInformation: lane.hayley@gene.com

► Study: Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular EdemaSponsor: Alimera SciencesStatus: Currently enrollingPurpose: To evaluate the pharmacokinetics, safety, and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edemaStudy Design: Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics StudyInclusion Criteria: Age ≥18 years with diabetic macular edema; diagnosis of diabetes mellitus types 1 or 2; BCVA of 19 letters; retinal thickness >250 μm by OCTExclusion Criteria: Glaucoma, ocular hypertension, IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents; retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy; prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months; prior intravitreal or subtenon anti-VEGF therapy within the last 2 months; any ocular surgery or retinal laser treatment within the last 3 monthsInformation: ghafiz@jhmi.edu

RETINAL VEIN OCCLUSION

► Study: The Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) StudySponsor: National Eye Institute/National Institutes of Health/Department of Health and Human ServicesStatus: Enrollment began in October 2004Purpose: To compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with CRVO and BRVODesign: Multicenter, randomized, phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of 3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide, or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. The preparation of triamcinolone acetonide used in the study is specially made for injection into the eye and does not contain any preservativesInclusion/Exclusion Criteria: Participants with macular edema associated with CRVO and BRVO ≥18 years of age and are willing to provide consent. Detailed inclusion/exclusion criteria are available on the SCORE Web site at http://spitfire.emmes.com/study/scoreNumber of Patients: 1260; 630 with CRVO and 630 with BRVOSite(s): 27Information: (301) 251-1161

► Study: Lucentis for Central Retinal Vein Occlusion (CRVO)Sponsor: California Retina Consultants/GenentechStatus: Enrolling patientsPurpose: To determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, CRVOStudy Design: Treatment, Randomized, Open-Label, Dose-Comparison, Crossover Assignment, Safety/Efficacy StudyNumber of Patients: Contact companyInclusion Criteria: Age >18 years; clinical evidence of perfused CRVO, defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants; central macular edema present on clinical examination and OCT testing with a central point thickness >250 μm; VA score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photographyExclusion Criteria: Pregnant women or premenopausal women not using adequate contraception; uncontrolled hypertension; significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; presence of another ocular condition that may affect the VA or macular edema during the course of the study; evidence of neovascularization of the iris or retina (presence of ischemic CRVO); presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study; history of grid/focal laser or Panretinal laser in the study eye; history of vitreous surgery in the study eye; history of use of intravitreal, peribulbar, or retrobulbar steroids within 6 months of the study; history of cataract surgery within 6 months of enrollment; history of YAG capsulotomy within 2 months of the surgery; visual acuity <20/400 in the fellow eye; uncontrolled glaucomaInformation: (805) 963-1648 ×26

► Study: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein OcclusionSponsor: AllerganStatus: Enrolling patientsPurpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusionDesign: Treatment, Randomized, Double-Blind, Dose-Comparison, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 650Inclusion Criteria: ≥18 years of age or older with macular edema resulting from retinal vein occlusion; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse); VA in other eye no worse than 20/200Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; diabetic retinopathy; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparinInformation: clinicaltrials@allgeran.com

► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein OcclusionSponsor: GenentechStatus: Currently enrollingPurpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVOStudy Design: TreatmentNumber of Patients: 390Inclusion Criteria: Foveal centerinvolved macular edema secondary to CRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographsExclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to Day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levelsInformation: (888) 662-6728

► Study: BRAVO: Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein OcclusionSponsor: GenentechStatus: Currently enrollingPurpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVOStudy Design: TreatmentNumber of Patients: 390Inclusion Criteria: Foveal centerinvolved macular edema secondary to BRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographsExclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to Day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levelsInformation: (888) 662-6728

► Study: Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein OcclusionsSponsor: Palo Alto Medical FoundationStatus: Currently enrollingPurpose: To determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye.Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy StudyNumber of Patients: 68Inclusion Criteria: Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusionExclusion Criteria: Active gout or high levels of uric acidInformation: gaynonM@pamf.org

UVEITIS

► Study: LUMINATE: A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-UveitisSponsor: Lux Biosciences, Inc.Status: Currently enrollingPurpose: To evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitisStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 210Inclusion Criteria: Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis; currently uncontrolled uveitis for a minimum of 2 weeks despite prednisone monotherapy at a dose of ≥10 mg/day (or equivalent) or ≥2 injections of corticosteroid (intravitreal or periocular) within the past 6 months or subjects for whom oral corticosteroid is contraindicated; grade of 2+ or higher for vitreous haze at time of enrollment; considered by the investigator to require corticosteroid-sparing therapy; not planning to undergo elective ocular surgery during the studyExclusion Criteria: Uveitis of infectious etiology; clinically suspected or confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitisInformation: clinicaltrials@luxbio.com

► Study: MUST: Multicenter Uveitis Steroid TreatmentSponsor: National Eye InstituteStatus: Currently enrollingPurpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.Study Design: Treatment, Randomized, Open-Label, Active Control, Parallel Assignment, Efficacy StudyNumber of Patients: 400Inclusion Criteria: Age ≥18; BCVA of 20/200 in at least 1 eye with severe uveitis; intraocular pressure 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitisExclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 antiglaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar; HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicatedInformation: (301) 451-2020

► Study: SITE: Systemic Immuno-suppressive Therapy for Eye Diseases Cohort StudySponsor: National Eye InstituteStatus: Currently enrollingPurpose: To evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancerStudy Design: Natural historyNumber of Patients: 6300Exclusion Criteria: No ocular inflammatory disease; infectious ocular inflammatory disease (eg, toxoplasmic retinitis, endophthalmitis, viral retinitis), unless the infectious uveitis followed treatment for a non-infectious ocular inflammatory diseaseInformation: (800) 411-1222

► Study: Immune Responses to Antigens in Non-Infectious Eye Inflammatory DiseasesSponsor: National Eye InstituteStatus: Currently enrollingPurpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatmentsStudy Design: Natural historyNumber of Patients: 200Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory diseaseInformation: (800) 411-1222

► Study: Study of Difluprednate in the Treatment of UveitisSponsor: Sirion TherapeuticsStatus: Currently enrollingPurpose: To determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitisDesign: Multicenter, randomized, double-masked, parallel-group, active-controlledNumber of Patients: 90Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterior uveitis in at least 1 eyeExclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease; allergy to similar drugs, such as other corticosteroidsContact: (813) 496-7325 ×300 or clinical. trials@siriontherapeutics.com

► Study: Phase 2 Study of MM-093 to Treat Patients With UveitisSponsor: Merrimack PharmaceuticalsStatus: Currently enrollingPurpose: To evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitisStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy StudyNumber of Patients: 20Inclusion Criteria: Documented diagnosis of sarcoid or birdshot uveitis for at least 6 months as defined by each of the following: inflammatory cells in the anterior chamber and/or vitreous body ≥2+; and loss of visual function as reflected by a prolongation of 30 Hz scotopic implicit time on ERG testing and/or loss of vision to the 20/40 level or lower on visual acuity testing for patients with birdshot retinochoroidopathyExclusion Criteria: Significant concurrent medical disease or prior medications or treatments up to 2 months before study beginsInformation: (617) 441-1000

► Study: Safety Study of 16.5mg (3.3%) CGC-11047 Injected Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to Age Related Macular DegenerationSponsor: CellGateInformation: http://www.clinicaltrials.gov/ct/show/NCT00446654?order=1

► Study: READ-2 (Ranibizumab for Edema of the mAcula in Diabetes)Sponsor: John Hopkins/Juvenile Foundation/GenentechInformation: http://www.clinicaltrials.gov/ct/show/NCT00407381?order=1